MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I SYPHILIS TP REAGENT KIT; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Catalog Number 07P60-77

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2021

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product list 7p60-77, that has a similar us product distributed in the us, list 07p60-21 / 31.An evaluation is in process.A followup report will be provided when the evaluation is complete.

Event Description

The account generated (b)(6) alinity i syphilis tp results on 2 patient that tested (b)(6).((b)(6) female) generated (b)(6) (serial (b)(4)), (b)(6) (serial (b)(4)), (b)(6) (serial (b)(4)), (b)(6) (serial (b)(4)), (b)(6) (serial (b)(4)).(b)(6) male) generated (b)(6) ((b)(4)), (b)(6) (serial (b)(4)), (b)(6) (serial (b)(4)), (b)(6) (serial (b)(4)), (b)(6) (serial (b)(4)).No additional patient information provided.No impact to patient management was reported.

Manufacturer Narrative

The ticket search by lot indicates that the reagent lot performs as expected for this product.The ticket trending review of complaint data for the likely cause list number does not identify any adverse trend.Labeling review concludes that the issue is adequately addressed.Device history record review was a review in the corrective and preventive actions system does not identify any non-conformances or deviations associated with the likely cause lot number and complaint issue.A retained reagent kit of the complaint lot was tested in a sensitivity setup.All specifications were met and no false non-reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.Based on all reviewed data, there is no general issue with the alinity i syphilis tp reagent lot identified in this complaint.No product deficiency was identified.

• Brand Name: ALINITY I SYPHILIS TP REAGENT KIT
• Type of Device: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12790850
• MDR Text Key: 282407156
• Report Number: 3002809144-2021-00644
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K153730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2021
• Device Catalogue Number: 07P60-77
• Device Lot Number: 23113BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 11/22/2021
• Supplement Dates FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESS MOD 03R65-01, AI02776, AI02774; ALINITY I PROCESS MOD 03R65-01, AI02776, AI02774